NDC 71770-120

Siklos

Hydroxyurea

Siklos is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medunik. The primary component is Hydroxyurea.

• Product ID: 71770-120_39756145-7b62-406e-bbe8-2771276fe543
• NDC: 71770-120
• Product Type: Human Prescription Drug
• Proprietary Name: Siklos
• Generic Name: Hydroxyurea
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-04-15
• Marketing Category: NDA / NDA
• Application Number: NDA208843
• Labeler Name: Medunik
• Substance Name: HYDROXYUREA
• Active Ingredient Strength: 1000 mg/1
• Pharm Classes: Antimetabolite [EPC], Urea [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71770-120-30

1 BOTTLE in 1 CARTON (71770-120-30) > 30 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2018-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71770-120-30 [71770012030]

Siklos TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208843
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-06

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYUREA	1000 mg/1

OpenFDA Data

• SPL SET ID: 76957c0d-0f98-4376-bb06-eee651adc09d
• Manufacturer:
  • Medunik
• UNII:
  • X6Q56QN5QC
• RxNorm Concept Unique ID - RxCUI:
  • 1999308
  • 1999316
  • 283475
  • 1999314

Pharmacological Class

• Antimetabolite [EPC]
• Urea [CS]
• Antimetabolite [EPC]
• Urea [CS]

NDC Crossover Matching brand name "Siklos" or generic name "Hydroxyurea"

NDC	Brand Name	Generic Name
71770-100	Siklos	Siklos
71770-120	Siklos	Siklos
71770-105	Siklos	Siklos
0003-6335	DROXIA	HYDROXYUREA
0003-6336	DROXIA	HYDROXYUREA
0003-6337	DROXIA	HYDROXYUREA
0003-0830	HYDREA	HYDROXYUREA
0093-0882	HYDROXYUREA	Hydroxyurea
0555-0882	HYDROXYUREA	Hydroxyurea
0904-6939	Hydroxyurea	Hydroxyurea
10135-702	Hydroxyurea	Hydroxyurea
24535-0831	Hydroxyurea	Hydroxyurea
42291-321	HYDROXYUREA	Hydroxyurea
49884-724	Hydroxyurea	Hydroxyurea
55154-3554	Hydroxyurea	Hydroxyurea
55154-7143	Hydroxyurea	Hydroxyurea